CMS Proposes Removing Two NCDs under Expedited Process

In 2013, CMS adopted an expedited administrative process to remove certain national coverage determinations (NCDs) older than 10 years since their most recent review. In December 2014, CMS removed seven NCDs under this process. On March 18, 2015, CMS proposed removing two more NCDs under this process, addressing coverage of Apheresis (therapeutic pheresis) and Smoking and Tobacco-Use Cessation Counseling (NCD Manual Section 201.4; Section 210.4.1 would remain). Public comments on this proposal will be accepted until April 17, 2015, and CMS expects to publish its determination by fall 2015. Local MACs are authorized to determine coverage for items and services that were previously governed by NCDs that were removed. 

CMS Invites Stakeholders to Join "Health Care Payment Learning and Action Network" to Promote Alternative Payment Models

As previously reported, CMS has established a public-private partnership, the Health Care Payment Learning and Action Network, to support HHS’s goal of moving Medicare and the broader health industry from a FFS model towards alternative payment models that emphasize value. CMS is now inviting payers, providers, employers, purchasers, state partners, consumer groups, individual consumers, and other interested parties to join the Network and participate in a kickoff event scheduled for March 25, 2015.

Among other things, the Network will: facilitate joint implementation of new models of payment and care delivery; define how best to report on new payment models; collaborate to generate evidence, share approaches, and remove barriers; develop common approaches to issues such as beneficiary attribution, financial models, benchmarking, quality and performance measurement, and risk adjustment; create implementation guides for payers, purchasers, providers, and consumers; and disseminate findings. In order to participate in the Network, interested parties must:

  • Support national goals for use of alternative payment models (e.g., accountable care organizations, bundled payments, and advanced primary care medical homes) for the U.S. health system that match or exceed the Medicare FFS goals (30% alternative payment model penetration by 2016 and 50% by 2018);
  • Agree that progress towards national goals should be measured;
  • Work with Network participants to establish standard definitions for alternative payment models;
  • Set organization-specific goals for alternative payment models within the first six months; and
  • Participate in reporting of progress towards national alternative payment model goals.

The Network will operate independently of HHS and other government entities, and its activities will be supported by an independent contractor that will act as a convener and produce “best practice” white papers.

CMS Report Assesses Effectiveness/Impact of Medicare Quality Measures

CMS has released the “2015 National Impact Assessment of Quality Measures Report,” which examines the effectiveness of quality measures used in CMS hospital, ambulatory, and post-acute quality programs. The report found that 95% of 119 publicly reported measure rates across seven quality reporting programs showed improvement from 2006 to 2012, with process measures most likely to be high performing. There were also achievements in reducing disparities in measure rates based on race and ethnicity. According to the report, CMS programs and measures reach a wide range of patients with high-impact medical conditions, although measures are not evenly distributed across CMS reporting programs. The report also considers measure alignment with other programs, impact beyond Medicare, measure exclusions, and other performance metrics. Numerous action items are suggested to guide future measure design and development. 

CMS Posts Initial Results for Physician Value-based Payment Modifier

 Under the ACA, the Physician Value-Based Modifier (Value Modifier) policy rewards physicians and groups of physicians who provide high quality and cost effective care, while penalizing those who did not meet objectives. Physicians in group practices of 100 or more eligible professionals who submit claims to Medicare under a single tax identification number are subject to the value modifier in 2015, based on performance in 2013. CMS has provided details on Value Modifier payment adjustments for applicable physician groups in 2015, including how groups that elected quality-tiering performed.

CMS Announces New "Next Generation" ACO Model; Schedules 3/17 Call

On March 10, 2015, CMS announced the Next Generation Accountable Care Organization (ACO) Model, its latest Affordable Care Act (ACA) innovation initiative intended to promote Medicare quality improvement and care coordination. The Next Generation ACO Model differs from the existing Medicare Shared Savings Program and Pioneer ACO models in several ways. For instance, the Next Generation ACO Model:

  • Provides higher levels of risk and reward, using what CMS characterizes as more stable, predictable benchmarking methods that reward both attainment and improvement in cost containment and that move away from comparisons to an ACO’s historical expenditures;
  • Offers a selection of payment mechanisms to shift from fee-for-service (FFS) reimbursement to capitation; and
  • Includes “benefit enhancement” tools to improve engagement with beneficiaries, including (1) greater access to home visits, telehealth services, and skilled nursing facilities; (2) opportunities to receive a reward payment for receiving care from the ACO; (3) a process to allow beneficiaries to confirm their care relationship with ACO providers; and (4) CMS-ACO collaboration to improve communication with beneficiaries about the potential benefits of ACOs.

CMS plans two rounds of applications for the Next Generation ACO Model in 2015 and 2016, with participation expected to last up to five years. Letters of Intent for the 2015 cycle are due May 1, 2015, and applications are due June 1, 2015.  CMS plans an “Open Door Forum” call to discuss the new model on March 17, 2015.

CMS Posts Deadlines for 2016 Medicare Shared Savings Program Application Cycle; Schedules Informational Calls

CMS is gearing up for the program year 2016 Medicare Shared Savings Program, under which physicians, hospitals, and certain other types of providers and suppliers may form Accountable Care Organizations (ACOs) to provide cost-effective, coordinated care to Medicare fee-for-service beneficiaries. CMS has posted the deadlines for applying to the program for 2016 (the notice of intent deadline is May 29, 2015, and the application deadline is July 31, 2015). In addition, CMS is hosting an April 7, 2015 call to discuss organizational structure and governance requirements, antitrust considerations, and the application process for January 2016 starters.  An April 21 call will cover ACO participant agreements, ACO participant lists, and beneficiary assignment. 

CMS Releases April 2015 Medicare Part B Drug ASP Update

CMS has posted its April 2015 update to the Medicare average sales price (ASP) drug pricing files, which contain the payment amounts CMS will use to pay for Part B covered drugs for the second quarter of 2015. According to CMS, prices for the top Part B drugs decreased by 0.6% on average compared to the previous quarter, and prices changed 2% or less for most of the higher-volume drugs.

CMS Schedules May 2015 Meetings on HCPCS Applications

CMS has announced that it is holding series of meetings in May 2015 to discuss pending  Healthcare Common Procedure Coding System (HCPCS) applications. The meeting dates are as follows:

May 7 & 8 -- Drugs/Biologicals/Radiopharmaceuticals/Radiologic Imaging Agents
May 21 & 22 -- Supplies and Other
May 27 -- Durable Medical Equipment (DME) and Accessories; and Orthotics and Prosthetics (O&P)

Deadlines and instructions for speaker and general registration and submission of comments are set forth in a notice to be published tomorrow.  Additional information, include preliminary coding determinations, will be posted in advance of each meeting at the CMS HCPCS website

CMS Invites Applications for Oncology Care Model

CMS is soliciting applications for organizations to participate in a new Oncology Care Model (OCM), which will test performance-based Medicare payment for episodes of care surrounding chemotherapy administration to cancer patients beginning in 2016. The model features a two-part payment system for participating practices: (1) a $160 monthly per-beneficiary-per-month payment for the duration of the episode, and (2) the potential for a performance-based payment for episodes of chemotherapy care to encourage practices to lower the total cost of care and improve care for beneficiaries during treatment episodes. The OCM is expected to start in the spring of 2016, and will last five years.

Hospital Engagement Network Contract Solicitation

CMS is requesting proposals for Hospital Engagement Network (HEN) contracts from qualified entities to work on reducing preventable hospital acquired conditions and readmissions through the Partnership for Patients initiative. HENs will engage the hospital, provider, and broader care-giver communities to quickly implement tested, evidence-based, and measured best practices in order to reduce hospital-based harm and preventable readmissions. 

CMS Raises the Bar for Nursing Home Quality Ratings under "Nursing Home Compare 3.0"

CMS has made revisions to the measurements used in the Nursing Home Compare Five Star Quality Rating System that have resulted in a decline in the star rating for about one-third of nursing homes. Specifically, on February 20, 2015, CMS added quality measures regarding the use of antipsychotics, revised the calculation of nursing home staffing levels, and strengthened the criteria for nursing homes to achieve top “star” ratings. According to CMS, before this “recalibration” (dubbed Nursing Home Compare 3.0), about 80% of nursing homes received either a 4 or 5-star quality rating; now about 49% will receive these top star ratings. The number of nursing homes receiving one star has increased from 8.5% to 13% after the recalibration. CMS advises consumers to rely on multiple factors in selecting a nursing home, however, including star ratings, visits, and reputation.

CMS Plans Spring Rulemaking to Modify Meaningful Use Requirements

CMS has announced that it plans to issue regulations this spring to address provider concerns about the burden associated with compliance with Medicare and Medicaid Electronic Health Record (EHR) Incentive Program meaningful use requirements. Specifically, in a January 29, 2015 blog post by Patrick Conway, MD, Deputy Administrator for Innovation and Quality and CMS Chief Medical Officer, CMS announced that upcoming regulations would:

  • Realign hospital EHR reporting periods to the calendar year facilitate hospitals incorporation of 2014 Edition software into their workflows and better align with other CMS quality programs;
  • Modify other aspects of the program to reduce complexity and lessen providers’ reporting burdens; and
  • Reduce the EHR reporting period in 2015 to 90 days to accommodate these changes.

These changes are separate from another rulemaking expected to be released next month that would address the Stage 3 meaningful use criteria for 2017 and subsequent years.

CMS Adds Star Ratings to Dialysis Facility Compare

On January 22, 2015, the Centers for Medicare & Medicaid Services (CMS) added star ratings to the Dialysis Facility Compare (DFC) website, with a one- to five-star rating assigned based on performance on nine quality measures. CMS plans to update the star ratings annually beginning in October 2015. CMS also announced plans to add the dialysis facility Standardized Readmission Ratio (SRR) to the data available on the DFC website, although it will not be included in the star rating at this time. 

Medicare DMEPOS Competitive Bidding Window is Now Open

The bidding window is now open for the Medicare Durable Medical Equipment, Prosthetics, Orthotics and Supplies (DMEPOS) Competitive Bidding Program Round 2 Recompete and the National Mail-Order Recompete for diabetic testing supplies. Bids will be accepted until March 25, 2015. Other key dates to note:

  • Registration to bid will close on February 17, 2015. Only suppliers that have registered and received a user ID and password will be eligible to submit bids.
  • The deadline to participate in the covered document review process is February 23, 2015. Under this process, suppliers may submit their required hardcopy financial documents to the Competitive Bidding Implementation Contractor (CBIC) in advance of the close of the bid window; suppliers will be notified if any individual financial documents are missing and have an opportunity to submit the missing documents.

Additional details are available at the CBIC web site.  

CMS Guidance on Provider Timeframes for Responding to Additional Documentation Requests

CMS has updated the Medicare Program Integrity Manual to clarify that providers and suppliers have 45 days to produce documents in response to a pre-payment review Additional Documentation Request (ADR) issued by a Medicare Administrative Contractor (MAC) or Zone Program Integrity Contractors (ZPIC). MAC and ZPIC reviewers are instructed not to grant extensions to providers who need more time to comply with such requests; instead, claims must be denied if the requested documentation is not received by day 46.

CMS Announces DMEPOS/Home Health/Hospice RAC, Improvements to RAC Process

CMS has announced that it has awarded the Region 5 Recovery Audit contract to Connolly, LLC (although the General Accounting Office subsequently reported that a bid protest has been filed regarding this award). The purpose of this contract will be to identify improper Medicare payments for durable medical equipment (DME), orthotics, prosthetics, and supplies and home health/hospice (HH/H) claims and work with CMS and the DME and HH/H MACs to adjust claims to recoup overpayments and pay underpayments. CMS observes that this award marks the beginning of the new Recovery Audit contracts, and it is the first contract to incorporate a series of changes intended to reduce the provider burden and increase program transparency (e.g., ADR limits, RAC accuracy threshold).

CMS Revises Down 1st Quarter 2015 Medicare Physician Fee Schedule (MPFS) Conversion Factor

CMS has posted a January 2015 release of the National Physician Fee Schedule Relative Value File, reflecting a conversion factor (CF) of $35.7547 – down slightly from the $35.8013 included in the 2015 final MPFS rule published on November 12, 2014.  CMS is expected to publish a notice explaining the reasons for the revised CF.  CMS had previously announced that it is holding Medicare physician claims for services furnished during the first two weeks of 2015 because of unspecified errors found in the MPFS final rule.  The claims hold is not expected to actually disrupt cash flow since clean electronic claims are not processed for 14 days anyway.

Note that the new CF applies only to services provided during the first three months of 2015, as a result of a temporary patch included in the Protecting Access to Medicare Act (PAMA) of 2014.  On April 1, 2015, the conversion factor is scheduled to be adjusted according to the statutory Sustainable Growth Rate (SGR) formula, resulting in an estimated 21.2% reduction -- unless Congress steps in and establishes an alternative conversion factor or otherwise reforms the SGR formula. Congress is expected to attempt to adopt a measure to prevent the scheduled April 1 SGR reduction from taking place.

CMS Releases 2015 Medicare Clinical Lab Fee Schedule Update

CMS has posted the 2015 update to the Medicare clinical laboratory fee schedule files

CMS Removes Seven Medicare National Coverage Determinations, Leaving Coverage to MACs

Yesterday CMS posted a Final Decision Memorandum for the Expedited Removal of National Coverage Determinations (NCDs).  By way of background, in an August 7, 2013 Federal Register notice (78 FR 48164), CMS established an expedited process for removing NCDs under certain circumstances, such as when they are no longer contain clinically pertinent or when the items or services are used infrequently by beneficiaries. Removal of an NCD does not necessarily result in noncoverage; instead, it allows the local Medicare Administrative Contractors (MACs) to determine coverage.

CMS reviewed NCDs that have not been reviewed in 10 years in order to evaluate the continued need for those policies to remain active on a national scale, and on November 27, 2013 CMS published for public comment the first list of NCDs proposed for removal. After review of public comments, CMS is now removing the following NCDs from the NCD Manual, effective December 18, 2014:

Continue Reading...

CMS Announces Timeline for Next Phase of DMEPOS Competitive Bidding

CMS has announced its detailed timeline for recompeting the supplier contracts awarded under Round 2 of the Medicare Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS) Competitive Bidding Program and the National Mail-Order diabetic testing supplies competition. All current Round 2 and National Mail-Order diabetic testing supplies contracts will be up for rebidding. The current contract period expires on June 30, 2016; the new contracts will begin on July 1, 2016. The first key date in the recompete cycle is December 18, 2014, when supplier registration for bidding opens, and the actual bid window opens on January 22, 2015. The full timeline is as follows (note that dates are subject to change):

Continue Reading...

Older Entries

December 9, 2014 — CMS Posts January 2015 Update to Medicare Part B Drug Pricing Files

December 8, 2014 — CMS Delaying Enforcement of Medicare Part D Drug Prescriber Enrollment Requirements

December 5, 2014 — CMS Issues Final Medicare Coverage with Evidence Development (CED) Guidance

December 2, 2014 — CMS Update on Status of Final Medicaid FULs

December 1, 2014 — CMS Releases 2015 Medicare DMEPOS Fee Schedule

November 20, 2014 — CMS to Expand Nursing Home MDS Focused Surveys

November 19, 2014 — CMS Updates Outpatient Therapy Caps for 2015

November 18, 2014 — CMS Delaying Enforcement of HIPAA Health Plan Enumeration/Health Plan Identifier Regulations

November 12, 2014 — CMS Releases 2015 HCPCS Files

November 6, 2014 — FDA Revises Guidance Defining Delays, Denials, Limits and Refusals of a Drug Inspection

October 28, 2014 — CMS Launches "Transforming Clinical Practice Initiative"

October 28, 2014 — CMS Announces ACO "Investment Model" Initiative to Support Care Coordination Nationwide

October 28, 2014 — CMS Solicits Suggestions for Potential PQRS Measures

October 28, 2014 — CMS Releases Medicare Advantage/Drug Plan Quality Data, Enforcement Statistics

October 28, 2014 — Update on CMS Medicare Appeals Administrative Agreement Offer

October 27, 2014 — Update on Sunshine Act "Open Payments" Public Data Review and Data Correction Deadline

October 10, 2014 — CMS Releases Preliminary Determinations for New 2015 Clinical Laboratory Fee Schedule Codes

October 8, 2014 — CMS to Revise Five Star Quality Rating System for Nursing Homes

October 8, 2014 — CMS Launches "Open Payments" Public Database; Usability Concerns Remain

October 6, 2014 — RACs Identified $3.75 Billion in Improper FFS Medicare Payments in FY 2013

October 2, 2014 — CMS Seeks Input on Potential Delivery Innovations in Medicare Part D, Medicare Advantage, & Other Programs

September 11, 2014 — CMS Updates Medicare Part B Drug Pricing Files

September 8, 2014 — Medicare Ambulance Update Factor for CY 2015

September 4, 2014 — CMS Offers Settlement to Acute Care Hospitals, CAHs to Resolve Patient Status Denial Appeals

August 28, 2014 — More Changes to Sunshine Act "Open Payments" Timeline

August 21, 2014 — CMS Fingerprint-Based Background Checks are Underway - Impacting "High-Risk" Providers and Suppliers

August 20, 2014 — CMS Revises Sunshine Act "Open Payments" System Review/Dispute Deadlines Amid Concerns about Data Accuracy

August 19, 2014 — CMS Seeks Innovative Models on Beneficiary Engagement and Behavioral Insights

August 12, 2014 — CMS Again Extends Moratoria on Enrollment of HHAs, Ambulance Suppliers in Designated Areas

August 12, 2014 — Medicare Intravenous Immune Globulin (IVIG) Demonstration Launched

August 12, 2014 — CMS to Restart RAC Reviews

August 12, 2014 — Sunshine Act "Open Payments" System Off to Rocky Start as Data Discrepancies Force System Off-Line

July 24, 2014 — Revised CMS Policy on Medicare Part D Drugs for Hospice Enrollees

July 24, 2014 — Sunshine Act Open Payments System Review/Dispute Process Underway

July 17, 2014 — CMS Announces Plans for Medicare DMEPOS Competitive Bidding Round 2 Recompete and National Mail-Order Recompete

July 2, 2014 — CMS Proposes Discontinuing 2 HCPCS Codes under New Demonstration

June 25, 2014 — HHS Provides Update on ACA Insurance Costs and Choices, Announces Management Changes

June 25, 2014 — CMS Adds MAC/RAC "Provider Relations Coordinator" for Auditor Process Issues

June 25, 2014 — CMS Plans Medicare Quality "Star" Ratings for Hospitals, Dialysis Facilities, Home Health

June 25, 2014 — CMS Releases Updated Hospital Charge Data, New Chronic Conditions & Geographic Variations Files

June 12, 2014 — CMS Releases July 2014 Medicare Part B Drug ASP Update

June 6, 2014 — Is anybody home? Medicare contractors on the prowl for DMEPOS supplier violations of posted business hours and other physical facility standards.

June 2, 2014 — CMS Abandons Plans to Finalize ACA Medicaid Drug Pricing Policy in July 2014

June 2, 2014 — CMS Announces New Public Comment Process on Requests to Discontinue HCPCS Codes

June 2, 2014 — HHS Launches Second Round of State Innovation Models Initiative

May 23, 2014 — CMS Extends Partial ICD-9-CM and ICD-10 Code Freeze to Reflect Transition Delay

May 15, 2014 — CMS to Implement Ordering/Referring Denial Edits for HHA Certifying Physicians, Effective July 1, 2014

May 14, 2014 — CMS Announces Reforms to Quality Improvement Organization Program

May 14, 2014 — CMS Extends "Hardship Exemptions" Policy for Health Insurance Purchasers

April 28, 2014 — CMS Announces Changes to Comprehensive End-Stage Renal Disease (ESRD) Care Initiative

April 28, 2014 — CMS Offers Guidance to Hospitals and States Ahead of DSH Compliance Audits

April 28, 2014 — CMS Posts First Medicare Inpatient Psychiatric Facility Quality Data

April 28, 2014 — CMS Issues Call for PQRS Quality Measures

April 16, 2014 — CMS to Implement Fingerprint-Based Background Checks for High-Risk Providers and Suppliers in 2014

April 10, 2014 — Will Physician Payment Sunshine Act Data Usher in a New Era of False Claims Act Litigation?

April 9, 2014 — CMS Releases Physician-Specific Medicare Charge/Payment Data

April 9, 2014 — CMS Announces Final 2015 Medicare Advantage/Part D Drug Plan Rates and Policies

April 8, 2014 — CMS Seeking Comments on Supervision Levels for Select Hospital Outpatient Services

April 8, 2014 — HHS Releases HIPAA Security Risk Assessment Tool

April 8, 2014 — CMS Extends Deadline for Individuals to Enroll in Health Insurance through Exchanges

March 25, 2014 — CMS Finalizes 2014 Policy on Medicare Payment for Hospice Enrollees' Drug Expenses

March 24, 2014 — CMS Releases Subregulatory Guidance on ACA Insurance Coverage, Exchange Issues

March 20, 2014 — CMS Expands Medicare EHR "Meaningful Use" Hardship Exception to Cover Vendor Issues

March 20, 2014 — Medicare Paper Claims Must Be Submitted on Revised 1500 Form By April 1, 2014

March 20, 2014 — Two-Midnight Inpatient Admissions Policy Guidance

March 19, 2014 — CMS Posts April 2014 Medicare Part B Drug ASP Files

March 18, 2014 — "Medicare Care Choices Model" to Allow Certain Hospice Patients to Seek Curative Care

March 4, 2014 — CMS Announces RAC Audit "Pause," Upcoming RAC Program Reforms

March 4, 2014 — CMS Posts Final HIPAA Administrative Simplification Transaction Testing Checklists

March 4, 2014 — CMS Continues to Modify Implementation of 2-Midnight Inpatient Admissions Policy

March 3, 2014 — CMS Proposes 2015 Payment, Policy Updates for Medicare Advantage and Drug Plans

March 3, 2014 — CMS Invites Suggestions for Advanced Diagnostic Imaging Quality/Safety Regulations

March 3, 2014 — CMS to Allow Retroactive ACA Insurance Subsidies for Certain Non-Marketplace Plans

February 18, 2014 — CMS Issues Draft Guidance for Qualified Health Plan Issuers for 2015

February 13, 2014 — CMS Considering Innovative Episode-Based Payment Models for Outpatient Specialty Practitioner Services

February 13, 2014 — CMS Again Extends "Probe & Educate" Phase for 2-Midnight Inpatient Admissions Criteria Implementation; Clarifies Physician Certification Requirements

February 12, 2014 — CMS Outlines 2013 "Sunshine Act" Open Payments Program Registration/Data Submission Process

January 15, 2014 — CMS Loosens Restrictions on Disclosure of Physician-Specific Medicare Payment Data

January 7, 2014 — CMS Steps Up Efforts Aimed at "Recalcitrant" Medicare Providers and Suppliers

January 7, 2014 — CMS Requests Feedback on ACO Initiatives

January 7, 2014 — CMS Revises Hospital Equipment Maintenance Requirements

January 7, 2014 — Hardship Exemption for Individuals with Cancelled Insurance Policies

January 6, 2014 — CMS Invites Comments on Medicare Payment for Hospice Enrollees' Drug Expenses

December 12, 2013 — CMS Releases 2014 Medicare DMEPOS Fee Schedule

December 10, 2013 — CMS Blog Post Announces Delay in Electronic Health Record (EHR) Incentive Program "Stage 3" Meaningful Use Start

December 10, 2013 — Final 2014 Medicare Clinical Lab Rates Set

December 10, 2013 — 2014 HCPCS Update Posted

December 10, 2013 — Updated Medicare Part B Drug Files Released

December 10, 2013 — CMS Proposes Removing 10 Medicare National Coverage Policies

December 9, 2013 — CMS Announces Plans to Finalize ACA Medicaid Drug Pricing Policy in July 2014

November 25, 2013 — CMS Releases Standard Consumer Notices under ACA Grandfathering/Transitional Policy

November 25, 2013 — CMS Letter to States on Quality Considerations for Medicaid and CHIP Integrated Care Models

November 14, 2013 — CMS Announces Medicare DMEPOS Bidding Round 1 Recompete Contract Suppliers

November 14, 2013 — CMS Guidance on Medicare Inpatient Hospital Admissions Two-Midnight Policy

November 14, 2013 — CMS Launches Virtual Research Data Center

November 14, 2013 — Applications for 2015 HCPCS Codes Due Jan. 3, 2014

November 12, 2013 — CMS "Phase 2" Ordering/Referral Denial Edits to Go Live on Jan. 6, 2014

November 11, 2013 — CMS Announces Inflation Update to "Sunshine Act" Reporting Thresholds for 2014

October 31, 2013 — CMS Expects Delay in Release of 2014 HCPCS Update and Final Coding Decisions

October 30, 2013 — Obama Administration Aligns Health Exchange Enrollment Deadline and "Shared Responsibility" Penalty Trigger